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Sr Reg Affairs Specialist

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Clonmel, TA, IE

Additional Locations: Ireland-Cork; Ireland-Clonmel; Ireland-Galway

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Requisition:  - Sr Reg Affairs Specialist

 

Job Purpose:


Responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects.

 

Key Responsibilities:


•    Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
•    Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
•    Develops and implements regulatory strategies for new and modified products.
•    Acts as a core member on new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions.
•    Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
•    Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
•    Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
•    Trains to departmental and divisional policies and procedures.
•    Supports highly technical or major business segment product lines, sterilization processes, special projects or strategic initiatives.
•    Fosters a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility. 
•    Fosters efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing

 

 
Required Qualifications:


•    A minimum of a Bachelor’s degree 
•    A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
•    Prior experience with regulatory submissions writing 
•    Basic understanding of product development process and design controls
•    Working knowledge of FDA, EU and international regulations
•    An understanding of standards, in particular the IEC 60601 series of standards as well as IEC 62304.
•    Ability to manage several projects simultaneously
•    Effective research and analytical skills
•    Excellent written and oral communication, technical writing and editing skills
•    Ability to work independently with minimal supervision
•    Strong interpersonal and influencing skills
•    Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)

 

Preferred Qualifications:


•    Bachelor’s degree in a scientific or technical discipline
•    Prior experience with submission writing, including PMA, 510(k), combination drug/device, implantable device, or active implantable device
•    General understanding of regulations applicable to the conduct of clinical trials
•    Experience with capital equipment, radio frequency, interoperability and usability engineering are a plus.

 

 

 

 

Requisition ID: 528496

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


Job Segment: RF, Compliance, Regulatory Affairs, Law, Product Development, Science, Legal, Research

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